FAQ

Important Safety Information: Spinal Cord Stimulation
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INDICATIONS

Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
CONTRAINDICATIONS
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Diathermy - Energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death.
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WARNINGS
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Sources of electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. Diabetic patients may have more frequent and severe complications with surgery. A preoperative assessment is advised for some diabetic patients to confirm they are appropriate candidates for surgery.
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PRECAUTIONS
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Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Avoid activities that put stress on the implanted neurostimulation system components. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site.
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ADVERSE EVENTS
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May include: undesirable change in stimulation (uncomfortable, jolting or shocking); hematoma, epidural hemorrhage, paralysis, seroma, infection, erosion, device malfunction or migration, pain at implant site, loss of pain relief, and other surgical risks. Adverse events may result in fluctuations in blood glucose in diabetic patients. Refer to www.medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events. Rx only. Rev 0422

Frequently Asked Questions

Does insurance cover this therapy?

When certain criteria are met, Medicare covers the trial and implantation of a spinal cord stimulator (SCS) when prescribed by your health care provider to treat diabetic peripheral neuropathy (DPN).
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Commercial and other insurance coverage varies depending on your plan.
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Your physician is encouraged, and may even be required, to obtain approval from your insurance company before proceeding with the procedure. We recommended that your physician verifies your insurance company’s SCS medical policy prior to scheduling a trial procedure.
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Most workers’ compensation carriers cover neurostimulators if approved before treatment.

Can I receive an MRI if I have the device implanted?

Medtronic offers full-body MRI access on all SCS devices*. Your Medtronic SCS device will never hold you back from getting a scan anywhere on your body if you need it.

*Under specific conditions. Refer to product labeling for a full list of conditions"

Will the implanted device give me the same pain relief as the trial?

The trial is designed to mimic what you will experience with the implanted device. Once you have the implant, your doctor will adjust the therapy to optimize your pain relief.

How big is the stimulator?

The stimulator is similar to a pacemaker. Medtronic has one of the smallest and thinnest implantable neurostimulators on the market, designed for patient comfort.
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Are there wires going into my spinal cord?

No. The leads are placed in the epidural space, an area near your spinal cord, but not in it.

Can I control the stimulation?

Your doctor will initially program the stimulator settings based on your needs and preferences, but you will be able to make adjustments with your handheld programmer.

Will this work better than my medications?

People with DPN are 17x more likely to experience significant pain relief if treated with SCS compared to conventional treatment.^1-3

Will I feel the stimulation?

It depends. Everyone is different. Some people do feel the stimulation. However, you can still get pain relief from SCS even if you don't feel the stimulation.

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van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcome in painful diabetic peripheral neuropathy: Five-year follow-up of a prospective two-center clinical trial. Diabetes Care. 2018;41(1):32–38. doi:10.2337/dc17-0983.
Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022.
de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicenter randomized clinical trial. Pain. 2014;155(11):2426–2431. doi:10.1016/j.pain.2014.08.031.2.